Intended for use in radiographic fluoroscopic applications including cardiar, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

Device Description

These CMOS X-ray detectors feature: The MX Imaging CMOS Flat Panel Detectors are designed for medical x-ray imaging applications. The CMOS panels are real-time x-ray detectors. The Detectors use a state of the art CMOS Imaging sensor that is based on a special pixel architecture enabling the detectors to be used in high sensitivity applications such as x-ray fluoroscopy/pulsed fluoroscopy, as well as applications requiring a large dynamic x-ray range such as radiography serial and radiography applications. The CMOS Flat Panel Detector is a component, and forms the part of a complete fluoroscopic x-ray system. The CMOS Detector interfaces to the Host X-Ray System through the associated interface connectors on the flat panel. The CMOS Flat Panel Detector is also synchronized to the X-Ray Generator via the interface cables. The intended use for this device is for Image Intensifier replacement in legacy surgical C-Arm systems.

AI/ML Overview

The provided document is a 510(k) premarket notification for MX Imaging, Inc.'s CFP-3131 and CFP-2222 X-ray detectors. This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for novel devices. Therefore, the information provided focuses on non-clinical testing against established standards and comparison to a predicate device.

Here's an analysis based on your request, highlighting what is and isn't available in this specific document:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria (e.g., in terms of imaging performance metrics like DQE, MTF, SNR values) and corresponding reported device performance values. Instead, it states that "Non-clinical testing was performed successfully according to the following standards" and lists regulatory standards and guidance documents. This implies that the device met the requirements outlined within those standards.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ANSI/AAMI ES60601-1:2005 +C1:2009 +A2:2020 +A1:3012 (Medical Electrical Equipment: General Requirements for Basic Safety and Essential Performance)	Tested successfully to this standard.
Compliance with IEC 60601-1-2:2007 (Medical Electrical Equipment: Electromagnetic Disturbances Requirements and Tests)	Tested successfully to this standard.
Compliance with 21 CFR 1020.30, 1020.31, and 1020.32 (US FDA Radiation Safety Performance Standard)	Meets the applicable requirements.
Compliance with FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (Sept 1, 2016)	Non-clinical testing performed in accordance with this guidance.
Consideration of Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance (Oct 2014)	Internal SOPs updated, cybersecurity precautions added to software user manuals.
Consideration of FDA's pediatric guidance ("Pediatric Information for X-ray Imaging Device Premarket Notifications")	Utilized in the preparation of labeling documentation.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Non-clinical testing was performed..." and "6. Clinical testing. Not required for a determination of substantial equivalence."

Therefore, there was no "test set" of patient data in the sense of a clinical study. The testing involved adherence to engineering and safety standards for the device itself.

Sample size for test set: Not applicable (no clinical test set).
Data provenance: Not applicable (no clinical data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical test set was used, no ground truth needed to be established by experts for such a set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an X-ray detector (hardware), not an AI-powered diagnostic tool. Therefore, an MRMC study assessing human reader performance with or without AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As noted above, this is for X-ray detector hardware, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of hardware submission, "ground truth" relates to the device meeting technical specifications and safety standards, rather than diagnostic accuracy against a clinical gold standard. The "ground truth" implicitly assumed is that the device, when combined with a compatible C-arm, produces diagnostic fluoroscopic X-ray images that are functionally equivalent to those produced by the predicate device and meet established safety and performance benchmarks.

8. The sample size for the training set

Not applicable. This device is hardware component (CMOS Flat Panel Detector), not an AI algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm.

Summary

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May 29, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" in a larger font size and a blue square behind it.

MX Imaging, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K201172

Trade/Device Name: CFP-3131, CFP-2222 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: April 29, 2020 Received: May 1, 2020

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201172

Device Name CFP-3131, CFP-2222.

Indications for Use (Describe)

Intended for use in radiographic fluoroscopic applications including cardiar, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the text '510(k) Summary K201172' in bold, black font. The text is centered on the image and is underlined. The text appears to be a title or heading for a document or section of a document.

Image /page/3/Picture/1 description: The image shows a logo with the letters "MX" in a stylized font. The "M" is black, and the "X" is blue. There is a white oval shape in the upper right corner of the "X". The logo is simple and modern.

MX Imaging Inc. 2894 Columbia Street Torrance CA 90503-3808 US 310-381-3800

Administrative Information 1.

Reason for Submission: 510(k) Notification for CFP-3131, CFP-2222. Submitter: MX Imaging Inc. Submission contact person: John Ross john-ross@mximaging.com Contact telephone: 310-381-3800 May 27, 2020 Date prepared:

2. Identification:	CFP-3131, CFP-2222.
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1650
Device Class:	Class II
Product Code:	OWB, JAA,

3. Substantially equivalent device:

Trade Name:	CS-series-FP with MX CFP 3131 or MX CFP 2222 Option
Manufacturer:	Omega Medical Imaging, LLC
510(k) #:	K171755
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1650
Device Class:	Class II
Product Code:	OWB, JAA,

4. Device description: These CMOS X-ray detectors feature:

The MX Imaging CMOS Flat Panel Detectors are designed for medical x-ray imaging applications. The CMOS panels are real-time x-ray detectors. The Detectors use a state of the art CMOS Imaging sensor that is based on a special pixel architecture enabling the detectors to be used in high sensitivity applications such as x-ray fluoroscopy/pulsed fluoroscopy, as well as applications requiring a large dynamic x-ray range such as radiography serial and radiography applications.

The CMOS Flat Panel Detector is a component, and forms the part of a complete fluoroscopic x-ray system. The CMOS Detector interfaces to the Host X-Ray System through the associated interface connectors on the flat panel. The CMOS Flat Panel Detector is also synchronized to the X-Ray Generator via the interface cables.

The intended use for this device is for Image Intensifier replacement in legacy surgical C-Arm systems.

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While we have tested the device with the GE/OEC 9800 and 9900 series of C-Arms it would be appropriate to install them in any standard Image Intensifier based system with the proper mechanical adapter (Weight compensated) and signal plug adaptations. The system provides a "Plug Compatible" device with the same outputs as the target system. For these reasons no modification of the host system is needed or recommended. In the case of the GE/OEC 9800 the existing input/output connect to the provided detector connectors without modification. Calibration software and instructions are provided with the detector. The existing software and controls all work as before.

1. Indications for Use: Intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

ComparableProperties	K171755 Omega CS-series-FPwith MX CFP 3131 or MX CFP2222 Optionradiographic/fluoroscopysystem	CFP-3131, CFP-2222. K201172	ComparisonResults
Indications foruse	Intended for use inradiographic/fluoroscopicapplications including cardiac,vascular, generalradiographic/fluoroscopicdiagnostic, and interventional x-ray imaging	Intended for use inradiographic/fluoroscopicapplications including cardiac,vascular, generalradiographic/fluoroscopicdiagnostic, and interventionalx-ray imaging	Identical
Digital X-RayDetectors	MX CFP 3131 and MX CFP 2222	CFP-3131, CFP-2222.	SAME
Detector Sizes	CFP 3131 – 327 x 377 mmCFP2222 – 235 x 292 mm	CFP-3131 – 327 x 377 mmCFP-2222 – 235 x 292 mm	SAME
Pixel Resolutions	CFP-3131 3096x3096CFP-2222 2170x2170,(1x1 binning)	CFP-3131 3096x3096CFP-2222 2170x2170,(1x1 binning)	SAME
Power Source	AC Line	AC Line	SAME.
Standards	Same as below	See below	SAME

6. Technological characteristics: Comparison Table

5. Non clinical testing: Testing was performed successfully according to the following standards:

StandardDevelopingOrganization	Standard DesignationNumber And Date	Title of Standard
ANSI/AAMI	ANSI/AAMI ES60601-1:2005 +C1:2009+A2:2020 +A1:3012	Medical Electrical Equipment Part 1: General RequirementsFor Basic Safety And Essential Performance

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StandardDevelopingOrganization	Standard DesignationNumber And Date	Title of Standard
IEC	60601-1-2:2007	Medical Electrical Equipment Part 12: General RequirementsFor Basic Safety And Essential Performance CollateralStandard: Electromagnetic Disturbances Requirements AndTests
Food and DrugAdministration	21CFR 1020.30,1020.31, and 1020.32Current Version	Meets the applicable requirements of the US FDA RadiationSafety Performance Standard

Non-clinical testing was performed in accordance with the FDA Guidance Document Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016. In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Druq Administration Staff October 2014. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals. Also we have utilized FDA's pediatric guidance, "Pediatric Information for X-ray Imaging Device Premarket Notifications" in the preparation of our labeling documentation. Conforms to applicable portions of the US Radiation Safety Performance Standard, conformance with applicable portions of 21 CFR 1020.30, 1020.31, and 1020.32.

Clinical testing. Not required for a determination of substantial equivalence.

7. Substantial Equivalence Discussion.

When combined with compatible c-arm combination the CFP 3131 - CFP2222 - performs the same functions using the same technological methods to produce diagnostic fluoroscopic x-ray images. In all material aspects, the Omega and the MX Imaging systems are substantially equivalent to each other.

8. Substantial Equivalence Conclusion:

After analyzing bench test results, risk analysis, and clinical evaluation, it is the conclusion of MX Imaging LLC that the CFP 3131 - CFP2222 - is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.